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Year-to-Date 2022 Reported Revenue Growth of 8% (16% at CER)
On-Track to Deliver Full-Year 2022 Double-Digit Revenue Growth of 15-20% at CER
Advancing Launch Preparation for AT-GAA in Pompe Disease
Updating Full-Year 2022 Non-GAAP Operating Expense Guidance from $470M-$485M to $430M-$440M
Conference Call and Webcast Today at 8:30 a.m. ET
PHILADELPHIA, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the quarter ended September 30, 2022.
Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “We remain laser focused on advancing our key strategic priorities for the year. The strong commercial uptake of Galafold® globally is on track to deliver double-digit operational growth in 2022. In addition, we are making great progress towards gaining regulatory approvals of AT-GAA for people living with Pompe disease around the world, and are well underway with our launch readiness. Through our continued commercial success with Galafold, our highly anticipated approvals of AT-GAA in the months ahead, together with our careful expense management, we believe Amicus is well positioned to drive significant value for shareholders and further our mission to bring innovative new medicines to people living with rare diseases.”
Corporate Highlights
| (in thousands) | Three Months Ended September 30, | Year over Year % Growth | Nine Months Ended September 30, | Year over Year % Growth | |||||||||||
| 2022 | 2021 | As Reported | at CER1 | 2022 | 2021 | As Reported | at CER1 | ||||||||
| Net Product Revenues | $81,691 | $79,545 | 3% | 14% | $241,137 | $223,360 | 8% | 16% | |||||||
Third Quarter 2022 Financial Results
2022 Financial Guidance
Anticipated 2022 Milestones by Program
Galafold (migalastat) Oral Precision Medicine for Fabry Disease
AT-GAA for Pompe Disease
1 In order to illustrate underlying performance, Amicus discusses its results in terms of constant exchange rate (CER) growth. This represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period. Full-year 2022 Galafold revenue guidance utilizes the average actual exchange rates for 2021.
2 Based on projections of Amicus non-GAAP Net Income under current operating plans, which includes successful AT-GAA regulatory approvals and continued Galafold growth. We define non-GAAP Net Income as GAAP Net Income excluding the impact of share-based compensation expense, changes in fair value of contingent consideration, loss on impairment of assets, depreciation and amortization, acquisition related income (expense), loss on extinguishment of debt, loss on impairment of assets, restructuring charges and income taxes.
3 Full reconciliation of GAAP results to the Company’s non-GAAP adjusted measures for all reporting periods appear in the tables to this press release.
4 A reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure is not available without unreasonable effort due to high variability, complexity, and low visibility as to the items that would be excluded from the GAAP measure.
Conference Call and Webcast
Amicus Therapeutics will host a conference call and audio webcast today, November 7, 2022 at 8:30 a.m. ET to discuss the third quarter 2022 financial results and corporate updates. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a personal PIN number to access the event.
A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com. Web participants are encouraged to register on the website 15 minutes prior to the start of the call. An archived webcast and accompanying slides will be available on the Company's website shortly after the conclusion of the live event.
About Galafold
Galafold® (migalastat) 123 mg capsules is an oral pharmacological chaperone of alpha-Galactosidase A (alpha-Gal A) for the treatment of Fabry disease in adults who have amenable galactosidase alpha gene (GLA) variants. In these patients, Galafold works by stabilizing the body’s own dysfunctional enzyme so that it can clear the accumulation of disease substrate. Globally, Amicus Therapeutics estimates that approximately 35 to 50 percent of Fabry patients may have amenable GLA variants, though amenability rates within this range vary by geography. Galafold is approved in more than 40 countries around the world, including the U.S., EU, U.K., and Japan.
U.S. INDICATIONS AND USAGE
Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene ( GLA ) variant based on in vitro assay data.
This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
U.S. IMPORTANT SAFETY INFORMATION
ADVERSE REACTIONS
The most common adverse reactions reported with Galafold (≥10%) were headache, nasopharyngitis, urinary tract infection, nausea and pyrexia.
USE IN SPECIFIC POPULATIONS
There is insufficient clinical data on Galafold use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.
It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.
Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis.
The safety and effectiveness of Galafold have not been established in pediatric patients.
To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information about Galafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/Galafold.pdf.
EU Important Safety Information
Treatment with Galafold should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. Galafold is not recommended for use in patients with a nonamenable mutation.
For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on Twitter and LinkedIn.
Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. Full reconciliations of GAAP results to the comparable non-GAAP measures for the reported periods appear in the financial tables section of this press release. When we provide our expectation for non-GAAP operating expenses on a forward-looking basis, a reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure generally is not available without unreasonable effort due to potentially high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure in the relevant future period, such as unusual gains or losses. The variability of the excluded items may have a significant, and potentially unpredictable, impact on our future GAAP results.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, manufacturing and supply plans, financing plans, and the projected revenues, expenses, cash position, and future profitability for the Company. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, and in particular the potential goals, progress, timing, and results of preclinical studies and clinical trials, including as they are impacted by COVID-19 related disruption, are based on current information. The potential impact on operations from the COVID-19 pandemic is inherently unknown and cannot be predicted with confidence and may cause actual results and performance to differ materially from the statements in this release, including without limitation, because of the impact on general political and economic conditions, including as a result of efforts by governmental authorities to mitigate COVID-19, such as travel bans, shelter in place orders and third-party business closures and resource allocations, manufacturing and supply chain disruptions and limitations on patient access to commercial or clinical product. In addition to the impact of the COVID-19 pandemic, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates; the potential that we may not be successful in commercializing Galafold in Europe, Japan, the US and other geographies or our other product candidates if and when approved; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we may not be able to manufacture or supply sufficient clinical or commercial products; and the potential that we will need additional funding to complete all of our studies, manufacturing and launch preparations. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. With respect to statements regarding projections of the Company's revenue, expenses, cash position, and future profitability, actual results may differ based on market factors and the Company's ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2021 and Form 10-Q for the quarter ended September 30, 2022, that was filed today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
CONTACTS:
Investors:
Amicus Therapeutics
Andrew Faughnan
Executive Director, Investor Relations
afaughnan@amicusrx.com
(609) 662-3809
Media:
Amicus Therapeutics
Diana Moore
Head of Global Corporate Communications
dmoore@amicusrx.com
(609) 662-5079
FOLD-G
TABLE 1
Amicus Therapeutics, Inc.
Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Net product sales | $ | 81,691 | $ | 79,545 | $ | 241,137 | $ | 223,360 | |||||||
| Cost of goods sold | 13,436 | 11,696 | 29,215 | 26,615 | |||||||||||
| Gross profit | 68,255 | 67,849 | 211,922 | 196,745 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 52,970 | 59,333 | 212,806 | 186,453 | |||||||||||
| Selling, general, and administrative | 47,272 | 46,107 | 158,767 | 135,109 | |||||||||||
| Changes in fair value of contingent consideration payable | 567 | 3,288 | (506 | ) | 4,780 | ||||||||||
| Loss on impairment of assets | — | — | 6,616 | — | |||||||||||
| Depreciation and amortization | 1,286 | 1,520 | 4,031 | 4,691 | |||||||||||
| Total operating expenses | 102,095 | 110,248 | 381,714 | 331,033 | |||||||||||
| Loss from operations | (33,840 | ) | (42,399 | ) | (169,792 | ) | (134,288 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 563 | 108 | 1,052 | 323 | |||||||||||
| Interest expense | (9,620 | ) | (8,165 | ) | (26,024 | ) | (24,307 | ) | |||||||
| Loss on extinguishment of debt | — | (257 | ) | — | (257 | ) | |||||||||
| Other income (expense) | 13,634 | 237 | 22,804 | (2,729 | ) | ||||||||||
| Loss before income tax | (29,263 | ) | (50,476 | ) | (171,960 | ) | (161,258 | ) | |||||||
| Income tax (expense) benefit | (4,023 | ) | 182 | (8,743 | ) | (5,925 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (33,286 | ) | $ | (50,294 | ) | $ | (180,703 | ) | $ | (167,183 | ) | |||
| Net loss attributable to common stockholders per common share — basic and diluted | $ | (0.12 | ) | $ | (0.19 | ) | $ | (0.63 | ) | $ | (0.63 | ) | |||
| Weighted-average common shares outstanding — basic and diluted | 289,223,709 | 267,464,637 | 288,841,092 | 266,085,788 | |||||||||||
TABLE 2
Amicus Therapeutics, Inc.
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
| September 30, 2022 | December 31, 2021 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 277,592 | $ | 245,197 | |||
| Investments in marketable securities | 77,108 | 237,299 | |||||
| Accounts receivable | 52,303 | 52,672 | |||||
| Inventories | 13,272 | 26,818 | |||||
| Prepaid expenses and other current assets | 38,264 | 34,848 | |||||
| Total current assets | 458,539 | 596,834 | |||||
| Operating lease right-of-use assets, net | 29,871 | 20,586 | |||||
| Property and equipment, less accumulated depreciation of $23,337 and $19,882 at September 30, 2022 and December 31, 2021, respectively | 32,449 | 42,496 | |||||
| In-process research & development | 23,000 | 23,000 | |||||
| Goodwill | 197,797 | 197,797 | |||||
| Other non-current assets | 17,872 | 24,427 | |||||
| Total Assets | $ | 759,528 | $ | 905,140 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 12,046 | $ | 21,513 | |||
| Accrued expenses and other current liabilities | 125,235 | 98,153 | |||||
| Contingent consideration payable | 19,833 | 18,900 | |||||
| Operating lease liabilities | 7,536 | 7,409 | |||||
| Total current liabilities | 164,650 | 145,975 | |||||
| Long-term debt | 391,319 | 389,357 | |||||
| Operating lease liabilities | 52,012 | 43,363 | |||||
| Deferred reimbursements | 5,906 | 5,906 | |||||
| Deferred income taxes | 4,930 | 4,930 | |||||
| Other non-current liabilities | 8,146 | 8,240 | |||||
| Total liabilities | 626,963 | 597,771 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock, $0.01 par value, 500,000,000 shares authorized, 280,887,136 and 278,912,800 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 2,813 | 2,808 | |||||
| Additional paid-in capital | 2,645,372 | 2,595,419 | |||||
| Accumulated other comprehensive (loss) gain: | |||||||
| Foreign currency translation adjustment | (38,724 | ) | 5,251 | ||||
| Unrealized loss on available-for-sale securities | (354 | ) | (270 | ) | |||
| Warrants | 83 | 83 | |||||
| Accumulated deficit | (2,476,625 | ) | (2,295,922 | ) | |||
| Total stockholders’ equity | 132,565 | 307,369 | |||||
| Total Liabilities and Stockholders’ Equity | $ | 759,528 | $ | 905,140 | |||
TABLE 3
Amicus Therapeutics, Inc.
Reconciliation of Non-GAAP Financial Measures
(in thousands)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Total operating expenses - as reported GAAP | $ | 102,095 | $ | 110,248 | $ | 381,714 | $ | 331,033 | ||||
| Research and development: | ||||||||||||
| Share-based compensation | 5,428 | 3,775 | 19,172 | 13,232 | ||||||||
| Selling, general and administrative: | ||||||||||||
| Share-based compensation | 9,344 | 8,066 | 38,714 | 30,699 | ||||||||
| Loss on impairment of assets | — | — | 6,616 | — | ||||||||
| Changes in fair value of contingent consideration payable | 567 | 3,288 | (506 | ) | 4,780 | |||||||
| Depreciation and amortization | 1,286 | 1,520 | 4,031 | 4,691 | ||||||||
| Total operating expense adjustments to reported GAAP | 16,625 | 16,649 | 68,027 | 53,402 | ||||||||
| Total operating expenses - as adjusted | $ | 85,470 | $ | 93,599 | $ | 313,687 | $ | 277,631 | ||||